MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT TRANSSEPTAL DILATOR; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Problems Difficult to Remove (1528); Defective Device (2588); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a watchman atrial fibrillation (a fib) procedure, a versacross connect kit was selected for use.The mechanical j-wire was very difficult to remove from dilator after reaching right atrium.Therefore, the guidewire and the dilator were removed together.When the guidewire was removed, it was noted that its coils were loose and bunching up at the opening of dilator.The mechanical guidewire remained in one piece and was not stretchable.No patient complications occurred.The procedure was completed successfully.The device is not expected to be returned for analysis as it was disposed.No other issues were noted.

• Brand Name: VERSACROSS CONNECT TRANSSEPTAL DILATOR
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17608070
• MDR Text Key: 321818427
• Report Number: 2124215-2023-43963
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 93 YR
• Patient Sex: Female
• Patient Race: White